VirusPhase 1WEENCT01159561
Western Equine Encephalitis Vaccine, Inactivated
A Phase 1 study testing Western Equine Encephalitis Vaccine in people with Virus, run by U.S. Army Medical Research and Development Command at 1 site in United States.
Trial summary
This study is designed to determine the safety and immunogenicity of WEE Vaccine Lot number 3-1-92. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Virus
- What is being tested?
- Western Equine Encephalitis Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Mar 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-55 years of age
- In good health as determined by pertinent medical history, brief physical exam, vital signs, and clinical safety laboratory evaluations
- Female: has a negative urine pregnancy test and is willing to use reliable form of contraception for the study duration
- Negative HIV antibody screen, seronegative for HBsAg and Hepatitis C antibody
- WEE, EEE, VEE, and CHIK PRNT80<1:10
- Ability to comprehend abnd a willingness to sign an informed consent, which includes the HIPAA and a separate HIV consent form
- Be willing to comply with all follow-up visits, testing, and AE reporting
Who cannot join
- Participant in the USAMRIID SIP
- Receipt of any other vaccine or investigational; drug within 30 days prior to study entry
- Anticipates receipt of other vaccines for the duration of the study (influenza vaccination will be permitted but not within 28 days of WEE vaccination
- Acute of chronic medical conditions, medications, or dietary supplements that, in the PI's opinion, would impair the subject's ability to respond to vaccination
- Hypersensitivity to any vaccine
- Allergic to any vaccine component: Human serum albumin, Neomycin
Show all 9Show fewer
- Receipt of or anticipates receipt of blood products during the study
- Female: Pregnant or breastfeeding
- Clinically significant abnormal laboratory tests (generally greater than or equl to 2 times the upper limit of normal as determined by the PI)
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Research Unit, Division of Medicine, USAMRIID
Fort Deterick, Maryland, 21702-5011
About this study
Official title: Phase 1 Study to Evaluate the Safety and Immunogenicity of the Western Equine Encephalitis (WEE) Vaccine, Inactivated, TSI-GSD 210, Lot 3-1-92, In Healthy Adults
This study is designed to determine the safety and immunogenicity of WEE Vaccine Lot number 3-1-92.
Read the detailed description
Study Objectives:
Primary: To assess safety of the Western Equine Encephalitis (WEE) Vaccine, Inactivated, TSI-GSD 210, lot 3-1-92.
Secondary: To evaluate immunogenicity of the Western Equine Encephalitis (WEE) Vaccine, Inactivated, TSI-GSD 210, lot 3-1-92.
- Conditions
- Virus
- Being tested
- Western Equine Encephalitis Vaccine
- Medical subject headings
- Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Western Equine Encephalitis VaccineBiological
Subject will be vaccinated with 0.5 mL of reconstituted WEE vaccine, inactivated, TSI-GSD 210 (Lot 3-1-92) subcutaneously in the upper outer aspect of the deltoid region.
| Study group | Role | What they receive |
|---|---|---|
| Vaccinated | Experimental | Western Equine Encephalitis Vaccine, Inactivated, TSI-GSD 210, Lot 3-1-92, administered in 0.5 mL doses subcutaneously in the upper outer aspect of the triceps in a 3-dose primary series (Days 0, 7, and 28) with a mandatory boost (Day 180) Receives: Biological: Western Equine Encephalitis Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects Reporting Adverse Events by Vaccination and Sex
Measured: 28 days following each vaccination
Secondary outcomes (1)
Immunogenicity
The primary endpoint used to measure immunogeniciyt of the WEE vaccine, the 80% plaque-reduction neautralization titer (PRNT 80), will be evaluated for subjects in the per protocol population.
The secondary endpoint will be GMT, with 95% CI, of the PRNT 80 for WEE-specific antibodies at each scheduled timepoint.
Measured: Baseline and multiple dates throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2010 (estimated)
- Study startFeb 2010
- Primary completionAug 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Ronald B Reisler, MD, Principal investigator, USAMRIID Medical Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01159561
- Sponsor's protocol ID
- A-15812
- Other IDs
- USAMRIID FY09-02
- Acronym
- WEE
- Status last verified
- Apr 2019
- First submitted
- 8 Jul 2010
- Last updated
- 29 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Keshtkar-Jahromi M, Reisler RB, Haller JM, Clizbe DP, Rivard RG, Cardile AP, Pierson BC, Norris S, Saunders D, Pittman PR. The Western Equine Encephalitis Lyophilized, Inactivated Vaccine: An Update on Safety and Immunogenicity. Front Immunol. 2020 Nov 9;11:555464. doi: 10.3389/fimmu.2020.555464. eCollection 2020.
PubMed 33240257
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study to Evaluate the Safety and Immunogenicity of the Western Equine Encephalitis (WEE) Vaccine, Inactivated, TSI-GSD 210, Lot 3-1-92, In Healthy Adults
- ClinicalTrials.gov ID
- NCT01159561
- Acronym / sponsor ID
- WEE / A-15812
- Conditions
- Virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Study start
- Feb 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 9 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to determine the safety and immunogenicity of WEE Vaccine Lot number 3-1-92.
Detailed description
Study Objectives:
Primary: To assess safety of the Western Equine Encephalitis (WEE) Vaccine, Inactivated, TSI-GSD 210, lot 3-1-92.
Secondary: To evaluate immunogenicity of the Western Equine Encephalitis (WEE) Vaccine, Inactivated, TSI-GSD 210, lot 3-1-92.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccinated | Experimental | Biological: Western Equine Encephalitis VaccineWestern Equine Encephalitis Vaccine, Inactivated, TSI-GSD 210, Lot 3-1-92, administered in 0.5 mL doses subcutaneously in the upper outer aspect of the triceps in a 3-dose primary series (Days 0, 7, and 28) with a mandatory boost (Day 180) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 18-55 years of age
- In good health as determined by pertinent medical history, brief physical exam, vital signs, and clinical safety laboratory evaluations
- Female: has a negative urine pregnancy test and is willing to use reliable form of contraception for the study duration
- Negative HIV antibody screen, seronegative for HBsAg and Hepatitis C antibody
- WEE, EEE, VEE, and CHIK PRNT80<1:10
Key exclusion criteria (9 listed)
- Participant in the USAMRIID SIP
- Receipt of any other vaccine or investigational; drug within 30 days prior to study entry
- Anticipates receipt of other vaccines for the duration of the study (influenza vaccination will be permitted but not within 28 days of WEE vaccination
- Acute of chronic medical conditions, medications, or dietary supplements that, in the PI's opinion, would impair the subject's ability to respond to vaccination
- Hypersensitivity to any vaccine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Western Equine Encephalitis VaccineSubject will be vaccinated with 0.5 mL of reconstituted WEE vaccine, inactivated, TSI-GSD 210 (Lot 3-1-92) subcutaneously in the upper outer aspect of the deltoid region. | Biological | Vaccinated |
Primary outcome
Subjects Reporting Adverse Events by Vaccination and Sex
Time frame: 28 days following each vaccination
1 secondary outcome
Immunogenicity
Time frame: Baseline and multiple dates throughout study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2019.
- Derived from this study: PubMed 33240257Keshtkar-Jahromi M, Reisler RB, Haller JM, Clizbe DP, Rivard RG, Cardile AP, Pierson BC, Norris S, Saunders D, Pittman PR. The Western Equine Encephalitis Lyophilized, Inactivated Vaccine: An Update on Safety and Immunogenicity. Front Immunol. 2020 Nov 9;11:555464. doi: 10.3389/fimmu.2020.555464. eCollection 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald B Reisler, MD principal investigator
USAMRIID Medical Division
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Western Equine Encephalitis Vaccine in people with Virus, run by U.S. Army Medical Research and Development Command at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjects Reporting Adverse Events by Vaccination and Sex (time frame: 28 days following each vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01159561, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2019.